CALCUSON

Device typeUltrasonic lithotripsy system: An assembly of devices designed to use ultrasonic (US) shock waves for the intracorporeal fragmentation of stones (calculi) found in the kidney, ureter, and bladder. This system can have a variety of configurations and will typically employ endoscopic devices together with a dedicated US transducer and probe (e.g., a sonotrode) during its application. The debris may be forcefully removed (e.g., through irrigation/suction) or passed out by natural means at a later date.

FDA categoryLithotriptor, ultrasonic

Device ID04048551085820

AvailabilityPrescription

MRI safetyLabeling does not contain MRI Safety Information